1. Field of the Invention
The present invention relates to medical methods and devices for performing sacral colpopexy.
2. Background Art
The sacral colpopexy operation is designed to recreate support to the upper vagina by attaching straps of permanent synthetic mesh to the upper anterior and posterior vaginal walls and then suspending the other end of the straps on the anterior surface of the sacrum. This operation is one of many operations described for the correction of pelvic organ prolapse but is considered the gold standard for correction of prolapse of the upper vagina. See, for example, “Long-Term Success of Abdominal Sacral Colpopexy Using Synthetic Mesh”, Culligan et al. Am J Obstet Gynecol (December 2002). This operation can be done either for correction of vaginal vault prolapse in patients who have previously undergone hysterectomy or can be done at the time of hysterectomy in patients with uterine prolapse. In the latter case, many physicians prefer to perform supracervical hysterectomy because of data suggesting that mesh related complications are less likely in cases of supracervical compared with total hysterectomy.
The sacral colpopexy operation was first described as being done through a large incision in the abdominal wall (laparotomy) and is still predominantly done in that manner.
FIG. 1 is a diagrammatic illustration of the surgery, which is usually performed under general anesthesia. An incision is made in the lower abdomen. The bladder and rectum are freed from the vagina and permanent mesh is secured to the sacrum (upper tailbone) to support the front and back wall of the vagina. The mesh is sutured to the vagina. The peritoneum (lining of the abdominal cavity) is closed over the mesh. There is growing interest in performing this operation via less invasive approaches, such as laparoscopy or robot-assisted laparoscopic surgery, but existing vaginal probes, surgical instruments and mesh configurations are not well-suited for this.
There are a variety of vaginal probes and mesh configurations designed for use in treating disorders of the female pelvic floor such as pelvic organ prolapse, urinary incontinence, and sexual dysfunction.
For example, U.S. Pat. No. 6,741,895 to Gafni et al. (Medoc Ltd.) issued May 25, 2004 shows a vaginal probe and method for stimulation of the nerves of the vagina with the purpose of testing their reaction to stimuli in the hope of defining, and treating sexual dysfunction in women. A balloon structure is used to provide tactile stimuli. When the balloon is inflated, these projections poke into the vagina.
United States Patent Application 20060199994 by Inman et al. (AMS Research) issued Sep. 7, 2006 shows surgical instruments useful in pelvic floor repair procedures. The claims require a handle attached to a slender, metal, curved rod.
United States Patent Application 20030220538 to Jacquetin issued 27 Nov. 2003 discloses a particular mesh implant for treating anterior vaginal prolapse.
U.S. Pat. No. 6,932,759 to Kammerer et al. issued Aug. 23, 2005 shows a surgical instrument and method for treating female urinary incontinence with a curved needle-like element and a proximal tape, or mesh, for implanting into the lower abdomen of a female to provide support to the urethra. A second curved needle element is used for simultaneous attachment to the distal end of the first needle.
The IVS Tunneller™ device is available from U.S. Surgical of Norwalk, Conn. The IVS device comprises a fixed delta wing handle, a hollow metal tube and a stylet that is placeable within the tube. The stylet has a rounded plastic tip on one end and an eyelet at the other end. The device may be used to implant a polypropylene tape for infracoccygeal sacropexy and other surgical procedures.
Although the foregoing references have some relevance, they are not suitable for sacral colpopexy, and would not be useful in this latter context. U.S. Pat. No. 6,328,729 (General Surgical Innovations) to Jervis issued Dec. 11, 2001 shows a colporrhaphy method and apparatus in which a tunneling member is advanced and a balloon inflated, thereby dissecting the anatomical space. Again, this device is designed to facilitate dissection of anatomical spaces and is not useful for sacral colpopexy.
United States Patent Application 20060015001 to Staskin et al. (American Medical) issued Jan. 19, 2006 shows a sling delivery system to treat urological disorders. The U-shaped configuration of the sling assembly also allows the sling to be adjusted during and/or after implantation. This device is designed for treatment of incontinence and neither it nor any of the foregoing devices are suitable for performance of sacral colpopexy.
United States Patent Application 20030195386 to Thierfelder et al. (AMS Research Corporation) issued Oct. 16, 2003 shows a surgical kit useful for performing a surgical procedure such as a sacral colpopexy with an implantable Y-shaped suspension for treating pelvic floor disorders such as vaginal vault prolapse. AMS also has a device called the Straight-In™ System which uses a long slender instrument designed for endoscopic use that screws a small coil of wire through the pre-formed Y-graft mesh and into the sacrum, thereby obviating the need to suture the mesh to the anterior longitudinal ligament of the sacrum. This device and the mesh are fairly described in the '386 patent application. Unlike the above-described references, this mesh configuration is created specifically for sacral colpopexy. However, there is no described means of stabilizing the mesh in the desired position during suturing of the mesh to the vagina.
Sacral colpopexy has been performed laparoscopically through multiple ports, in one case three to four ports for a daVinci® robot, and one or two ports for the assistant. The polypropylene mesh was attached robotically to the sacral promontory and to the vaginal apex using Gortex™ sutures. Whether performed manually or robotically, there are still inherent problems with manipulating the end effectors and stabilizing the vagina.
Performing the operation laparoscopically using currently available equipment has several inefficiencies. One of the problematic areas in performing laparoscopic or robotic sacral colpopexy is introduction and positioning of the mesh straps during suturing of the mesh to the vagina. Guiding them into proper orientation is awkward. Maintaining them in the proper position during suturing requires constant vigilance on the part of the assistant as they frequently require repositioning. Additionally, maintaining the mesh straps in position occupies one or more instruments that could be utilized elsewhere (for instance in retracting the surrounding tissues for better visualization). Sometimes portions of the mesh will drape over and obscure the site of interest, particularly during suturing the posterior strap of mesh to the posterior vaginal wall.
It has been proposed in other contexts to stabilize one surgical instrument using a second instrument inserted through another incision. For example, U.S. Pat. No. 7,052,453 to Presthus et al. (Solorant Medical) issued May 30, 2006 shows an incontinence treatment with urethral guide that docks with a probe. Generally, the guide can be inserted into a first body orifice and the probe can be inserted into a second body orifice and placed in a predetermined position relative to the guide so as to position the treatment surface adjacent the target tissue in the second body orifice. The urethral guide and probe may align RF sensors relative to a tissue surface.
It would be greatly advantageous to provide a mesh delivery system that overcomes the alignment and positioning problems using a docking concept as above, rendering the mesh attachment for sacral colpopexy more efficient. If the operation can be rendered more efficient, i.e., less time consuming, and with a lower learning curve, there is potential for the operation to be transformed in to one that is done primarily laparoscopically, similar to what has already occurred with cholecystectomy (removal of the gall bladder).